QA Risk Manager
Location: GermanySIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Biotechnology and Pharmaceutical organization, based in Baden-Württemberg Germany.
Our client is a global Pharma company in Germany.
ROLE DESCRIPTION
Our client is looking for a QA specialist with Pharma and Medical Device experience dealing with combination products.
RESPONSIBILITIES
- Compliance and implementation of regulations for devices and biologics
- Maintain and improve QA Risk Management procedures
- Work together with R&D, Operations, Sales and Marketing and other departments
- Coordinate design changes and design control of combination products
- Ensure QA regulatory compliance
REQUIREMENTS
- B.Sc. / Bachelor in Chemistry, Pharmacy, Biology, Microbiology, Engineering or related
- 5+ years experience with QA QMS
- Leading team experience
- Knowledge of ICH, ISO, US Code, FDA and EU regulations
- Experience in dealing with regulatory authorities
- Excellent English skills
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact admin admin.
